ABC-BIO case studies
ABC-BIO · Put your knowledge to work in context.
The ABC-BIO is listed on this site as a Bioanalytical Chemistry exam, but the only page we were able to retrieve for it does not contain an exam profile. The URL https://www.abcc.org/bioanalytical-chemistry/ returned a 404 'page not found' page belonging to the Arabic Bible Christian Church in Long Beach, California, so the page carried navigation links, a media search box, an address, an email address and a phone number, but no information about the credential itself. The ABC-BIO case studies are 5 cases and about 3,521 words.
1Bioanalytical Method Transfer: Partial Validation for a New Matrix
A validated LC-MS/MS method for quantifying drug X in human plasma (K2EDTA) is being transferred to a new laboratory for a clinical trial that will also collect urine and dried blood spot (DBS) samples. The original validation included calibration curves (1–1000 ng/mL), QC samples at 3, 30, and 800 ng/mL, and stability in plasma.
613 words, about 3 min2Incurred Sample Reanalysis (ISR) Failure: Investigating the Root Cause
During a regulated bioanalytical study for drug Y in human plasma, incurred sample reanalysis (ISR) was performed on 60 samples. The ISR acceptance criterion is that at least 67% of the samples must have percent difference (%Diff) within ±20% of the mean of the original and repeat values.
702 words, about 4 min3Calibration Curve Failure in a Bioanalytical Run: Impact on Sample Reporting
A bioanalytical run for drug Z in human plasma includes a calibration curve (8 non-zero standards, 1–500 ng/mL), blank and zero samples, and 40 study samples. The run also includes QCs at 5, 50, and 400 ng/mL (n=6 each).
751 words, about 4 min4Internal Standard Variability in LC-MS/MS: When to Reject a Batch
A bioanalytical batch for drug W in human plasma (LC-MS/MS, positive ion mode) includes 10 calibration standards, 6 QCs at three levels, and 30 study samples. The internal standard (IS) is a stable isotope-labeled analog.
753 words, about 4 min5Stability Testing in Biological Matrix: When Does a Failed Stability Compromise Study Data?
A bioanalytical method for drug V in human plasma has been validated, including stability in plasma at room temperature for 6 hours, at 4°C for 24 hours, and at −80°C for 12 months. During a clinical study, samples were collected and stored at −80°C for up to 18 months before analysis.
702 words, about 4 min